SHISEIDO ULTIMATE SUN PROTECTOR- octisalate, homosalate, octocrylene, and avobenzone lotion

SHISEIDO ULTIMATE SUN PROTECTOR by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTOR by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICAS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octisalate 5.0%	Sunscreen
Avobenzone 2.3%	Sunscreen
Homosalate 10.0%	Sunscreen
Octocrylene 5.0%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable: Do not use near heat, flame, or while smoking.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

:WATER▪DIISOPROPYL SEBACATE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪DIMETHICONE▪PEG/PPG-9/2 DIMETHYL ETHER▪SD ALCOHOL 40-B▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TRIETHYLHEXANOIN▪GLYCERIN▪DEXTRIN PALMITATE▪SUCROSE TETRASTEARATE TRIACETATE▪ISODODECANE▪PPG-3 DIPIVALATE▪TRIMETHYLSILOXYSILICATE▪SILICA▪SODIUM CHLORIDE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪PPG-17▪DISTEARDIMONIUM HECTORITE▪CALCIUM STEARATE▪ISOSTEARIC ACID▪PALMITIC ACID▪TRISODIUM EDTA▪ALCOHOL▪SILICA DIMETHYL SILYLATE▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪PEG-6▪BHT▪TOCOPHEROL▪BUTYLENE GLYCOL▪STEARIC ACID▪SODIUM METABISULFITE▪SYZYGIUM JAMBOS LEAF EXTRACT▪POLYSILICONE-2▪METHYLPARABEN▪FRAGRANCE▪IRON OXIDES▪

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protector Lotion

50+

SynchroShield
WetForce x HeatForce

Turns Invisible

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTOR 
octisalate, homosalate, octocrylene, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-481
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.762 g  in 150 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15.525 g  in 150 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.762 g  in 150 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.57 g  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
TALC (UNII: 7SEV7J4R1U)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PPG-17 (UNII: OV0Q322E0U)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CALCIUM STEARATE (UNII: 776XM7047L)
ISOSTEARIC ACID (UNII: X33R8U0062)
PALMITIC ACID (UNII: 2V16EO95H1)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALCOHOL (UNII: 3K9958V90M)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-481-10	1 in 1 CARTON	01/01/2020
1		150 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-481) , ANALYSIS(58411-481)